Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose

NCT ID: NCT03933852

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-08
• Study Completion Date: 2024-12-31

Brief Summary

Additional information is needed to characterize the safety profile of ponatinib as it is used in routine clinical practice in Europe. This observational cohort study will provide a real-life picture of ponatinib use in clinical practice and additional quantification and characterization of adverse events (AEs) and their outcomes in patients with Chronic Myeloid Leukemia in any phase treated with ponatinib.

Detailed Description

This study is a multicentre, long-term, prospective and retrospective, observational cohort study of patients who are treated with ponatinib. The study is non-interventional; all Treatment decisions are made at the discretion of the patient's healthcare provider (HCP) and are not mandated by the study design or protocol.

A heterogeneous sample of oncology practice sites in Germany (both Hospitals and Field based Haematologists) treating adult patients with Chronic Myeloid Leukemia in any phase using ponatinib will be selected for participation in the study. Eligible, consenting patients initiating treatment with ponatinib will be enrolled into the prospective part of the study. Eligible consenting patients with Chronic Myeloid Leukemia in any Phase that have initiated ponatinib outside clinical trial after its approval in Germany will be enrolled in the retrospective part of the study.

Approximately 100 patients will be enrolled from approximately 50 sites. The patient enrolment period is estimated to be approximately two years. Patients who experience an Adverse Event (AE) during treatment or within the 30 days post discontinuation will be followed for 12 months to determine the consequences of the Adverse Event. Data on patient's history, patient's data at baseline, ponatinib treatment, Adverse Events, all medications received, and efficacy measures will be collected during the study in conjunction with routine care visits, anticipated to be approximately every 3 months.

Information on any new therapies, including treatment for Chronic Myeloid Leukemia and other medications will be collected during follow-up.

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Adult patients (age ≥18 years) with Chronic Myeloid Leukemia in any phase who are initiating ponatinib monotherapy, or for whom ponatinib monotherapy was initiated after ponatinib approval in Germany. [The decision to prescribe ponatinib must have been made prior to enrolment in the study. Patients enrolled in the retrospective part of the study may or may not be still on ponatinib treatment at the time informed consent is given. These retrospective patients should have started Treatment after 02.02.2015.].
• Patients who have the ability to understand the requirements of the study, and provide written informed consent to comply with the study data collection procedures.
• Patients with a minimum life expectancy of 3 months

Exclusion Criteria

• Patients previously treated with investigational ponatinib (within a clinical trial)
• Patients receiving an investigational agent
• Patients who are pregnant and/or breastfeeding
• Patients who are pregnant and/or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Andreas Hochhaus

Director Clinic of Internal Medicine II

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Hochhaus

Role: PRINCIPAL_INVESTIGATOR

University Hospital Jena

Locations

University Hospital Jena

Jena, , Germany

Countries

Germany

Other Identifiers

Ponderosa

Identifier Type: -

Identifier Source: org_study_id